Senior eClinical Systems Analyst
PuneFull-time3–6 yrsPosted 4 months ago
Mid-level software engineering role at Transperfect in Pune. Needs 3+ years.
About the role
Senior eClinical Systems Analyst is responsible for assisting clients with the development, maintenance and closeout of clinical trials, using a number of eClinical systems including but not limited to: e TMF, Study Start up (SSU) and Clinical Trial Management System (CTMS). The person in this position will be someone who is highly experienced with eClinical systems, particularly the clinical trial process around the quality of the TMF.
What you'll do
- Create and complete billable TMF quality reviews to ensure document content and metadata application are accurate and to ensure documentation is present/complete in the…
- Periodic quality reviews for each active study site for all regulatory documents, including: IRB Renewal, IRB Protocol Approval, Informed Consent Review
- Complete regulatory document review and compilation of documents for FDA submissions using GCP and ICH guidelines
- Draft, review and approve TMF Quality plans and reports and reconciliation of findings
- Communicate all systematic filing issues to the manager for further training evaluation
What you need
- Clinical research
- GCP
- CRO
- Reconciliation
- PowerPoint